Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation
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| ClinicalTrials.gov Identifier: NCT02720536 |
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Recruitment Status :
Completed
First Posted : March 28, 2016
Results First Posted : March 3, 2020
Last Update Posted : March 3, 2020
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
Extend evaluation of deferasirox film-coated tablet (FCT) formulation
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Iron Overload | Drug: Deferasirox | Phase 3 |
Collection of additional safety and efficacy data with deferasirox film-coated tablet (FCT) in patients who had completed study CICL670F2201
- Provide patients who completed 24 weeks of treatment in the core study, CICL670F2201, the possibility to have additional treatment with the deferasirox FCT.
- Collect additional longer term data on the safety and the tolerability of the deferasirox FCT.
- Collect efficacy data on the deferasirox FCT in reduction or maintenance of iron burden as measured by serum ferritin level.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 53 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Open-label, Multicenter, Single Arm, Phase III Study to Collect Additional Safety and Efficacy Data With Deferasirox Film-coated Tablets in Patients Completing Study CICL670F2201 |
| Actual Study Start Date : | August 16, 2016 |
| Actual Primary Completion Date : | July 23, 2019 |
| Actual Study Completion Date : | July 23, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Iron
Drug Information available for:
Deferasirox
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Deferasirox
Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight.
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Drug: Deferasirox
Deferasirox FCT will be provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use. |
Primary Outcome Measures :
- Overview of Number of Participants With Adverse Events [ Time Frame: Baseline up to approximately 25 months ]Numbers represent counts of participants within the categories. An adverse event (AE) was defined as treatment emergent if its onset date is on or after (≥) the first administration of study treatment within this study or events present prior to start of study treatment but increased in severity on or after (≥) the first administration of study treatment within this study but not later than 30 days after the last study treatment in this study
- Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12 [ Time Frame: Baseline, 6 and 12 months ]The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
- Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12 [ Time Frame: Baseline, 6 and 12 months ]The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
- Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12 [ Time Frame: Baseline, 6 and 12 months ]The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
- Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12 [ Time Frame: Baseline, 6 and 12 months ]The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
- Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12 [ Time Frame: Baseline, 6 and 12 months ]The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
- Change From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12 [ Time Frame: Baseline, 6 and 12 months ]The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
- Change From Baseline Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) (U/L) at Month 6 and Month 12 [ Time Frame: Baseline, 6 and 12 months ]The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Secondary Outcome Measures :
- Change From Baseline of Serum Ferritin Level (ug/L) at Month 6 and 12 [ Time Frame: Baseline, 6 and 12 months ]The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline. A negative change from baseline is regarded as an improvement in this study
- Percentage Relative Change From Baseline of Serum Ferritin (%) at Month 6 and 12 [ Time Frame: Baseline, 6 and 12 months ]The percentage relative change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Percentage relative change = 100 × ([Post - Baseline] / Baseline). Percentage relative change is calculated for each patient individually and then overall descriptive summary statistics is obtained for subjects with a value at baseline and the particular time point. A negative percentage relative change from baseline is regarded as an improvement in this study
Information from the National Library of Medicine
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| Ages Eligible for Study: | 10 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria for subjects:
- Completed 24-weeks of study treatment as described in the core protocol (CICL670F2201).
- Were deemed to have tolerated deferasirox treatment by the investigator.
- Provided written informed consent/assent before any study-specific procedures were performed. For pediatric patients, consent was obtained from parent(s) or legal patient's representative. Investigators were to have also obtained assent of patients according to local, regional or national guidelines.
Key Exclusion for subjects:
The exclusion criteria followed those described for the core protocol CICl670F2201, which were as follows:
- Creatinine clearance below the contraindication limit in the locally approved prescribing information.
- Serum creatinine > 1.5 × upper limit of normal range (ULN) at Screening
- Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) > 5 × ULN,
- Significant proteinuria
- Patients with significant impaired gastrointestinal function or gastrointestinal disease
- Clinical or laboratory evidence of active Hepatitis B or Hepatitis C
- Patients with psychiatric or addictive disorders
- Patients with a known history of HIV seropositivity (Elisa or Western blot).
- History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there was an evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- Patients with a history of hypersensitivity to any of the study drug or excipients.
- Patients with significant medical condition that could interfere with the ability to participate in this study
- Patients who were participating in another clinical trial or receiving an investigational drug.
- Patients using prohibited medication,
- Patients with liver disease with severity of Child-Pugh Class B or C.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using effective methods of contraception during dosing of study treatment
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720536
Locations
| Austria | |
| Novartis Investigative Site | |
| Vienna, Austria, 1140 | |
| Greece | |
| Novartis Investigative Site | |
| Goudi-Athens, GR, Greece, 115 27 | |
| Novartis Investigative Site | |
| Patras, Greece, 265 00 | |
| Novartis Investigative Site | |
| Thessaloniki, Greece, 54642 | |
| Italy | |
| Novartis Investigative Site | |
| Catania, CT, Italy, 95125 | |
| Novartis Investigative Site | |
| Cona, FE, Italy, 44100 | |
| Novartis Investigative Site | |
| Genova, GE, Italy, 16128 | |
| Novartis Investigative Site | |
| Cagliari, ITA, Italy, 09121 | |
| Novartis Investigative Site | |
| Lecce, LE, Italy, 73100 | |
| Novartis Investigative Site | |
| Milano, MI, Italy, 20122 | |
| Novartis Investigative Site | |
| Palermo, PA, Italy, 90127 | |
| Novartis Investigative Site | |
| Palermo, PA, Italy, 90146 | |
| Novartis Investigative Site | |
| Verona, VR, Italy, 37126 | |
| Novartis Investigative Site | |
| Napoli, Italy, 80138 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Documents (Full-Text)
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan [PDF] August 26, 2019
Study Protocol [PDF] October 25, 2017
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02720536 |
| Other Study ID Numbers: |
CICL670AIC04 |
| First Posted: | March 28, 2016 Key Record Dates |
| Results First Posted: | March 3, 2020 |
| Last Update Posted: | March 3, 2020 |
| Last Verified: | February 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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adult pediatric, anemia. Myelodysplastic Syndrome Thalassemia Film coated tablet |
ICL670 MDS Chelation Deferasirox Iron overload |
Additional relevant MeSH terms:
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Iron Overload Iron Metabolism Disorders Metabolic Diseases Deferasirox |
Iron Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |